Engineering Documentation Control Lead / Pharma Industry from Pioneer Data Systems
West Conshohocken, PA 19428
About the Job
Our client, a world-leading Pharmaceutical Company in Conshohocken, PA is currently looking for a Engineering Documentation Control Lead to join their expanding team.
Position Details:
- Job Title: Engineering Documentation Control Lead / Pharma Industry
- Duration: 12 months contract, extendable up to 24 months
- Location: Conshohocken, PA
Travel:
- For the first 6 months of the role, it will be remote - supporting sites in PA. Will need to travel to PA 25% of the time in the first 6 months of the position
- The role will officially move to the Wilson, NC site mid-year 2025; it will be onsite in Wilson/NC mid-year 2025
- Will travel to Ireland up to possibly 3 times in the first 6 months for training, that can be 1-2 weeks long in duration. Travel will be reimbursed/covered.
Note:
- The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
- You may participate in the company group medical insurance plan
Job Description:
- Title: Engineering Documentation Control Lead
Location: Should be local to Wilson, NC or nearby. For the first 6 months of the role, it will be remote supporting sites in PA. The role will officially move to the Wilson, NC site mid-year 2025 - Should source out of NC, where candidates can commute to Wilson, NC to be onsite
- The role will be remote for the 1st 6 months, supporting sites in PA
- Must be able to travel to PA sites once a month during the first 6 months
- Will be required to do some international travel, to Ireland up to 1 trip in the first 6 months for training (trip could last 1-2 weeks)
- Should have a valid/active passport
- Then the role will move to Wilson, NC and will be 100% onsite
- This role requires experience as Engineer Document Control Lead
- Must have at least 7 years of exp
- Exp with large capital projects
- Document control exp
- Exp with engineering drawings/instructions
- Knowledge of construction interface
- Exp with technical document review
Duties and Responsibilities:
- Define and develop an electronic EDC process, such that all documents and drawings handover over are digital only (i.e. no paper) and the process is in alignment with enterprise electronic document standards.
- Ensure correct definition of Supplier Documentation Index (SDI) for all Vendor and Trade packages.
- Coordinate review and approval of drawings and documents (e.g. Engineering, C and Q, Maintenance, Automation).
- Ensure all signoffs of turnover packs in a timely manner, as per project schedule requirements.
- Expedite closure of all queries and comments from document reviews.
- Adhere to project schedule targets, particularly those associated with the handover of documentation at both Mechanical Completion (Green Tag) and Commissioning and Qualification (Blue Tag) phases.
- Ensure documents are uploaded as they become available, in a progressive manner, to level load the review and approval process and prevent bottle necks.
- Track progress using KPIs, e.g. document submissions from vendors, % complete of each VTOP/TTOP, review and approval status, due dates for completion, etc.
- Manage an Issue Resolution tracker, to track all potential issues, delays, etc.
- Adequately resource document TTOP review process, to allow for peaks and troughs, to ensure no backup of progress.
- Audit VTOP/TTOP content quality throughout the process, to ensure alignment with expected standards.
- Ensure as-built P and IDs for all elements of project. (In Smart format and in Non-Smart CAD - AutoCAD 2019 is the current set-up format, with associated layers.)
- Incorporate all intervening site changes to any existing P&IDs, including all x-ref changes.
- Ensure redraft of all Vendor P and IDs to format.
- Ensure all project A/E and Vendor drawings are handed over in the correct format.
- Ensure all turnover packs, drawings and P and IDs are correctly and accurately uploaded to Meridian.
Preferred Qualifications:
Essential
- BSc or Diploma qualification (Engineering related discipline).
- At least 10 years EDC experience and a proven track record within a cGMP regulated environment.
- At least one major GMP manufacturing plant capital project as an EDC Lead.
- Planning and organizing skills.
- Excellent interpersonal and influencing skills.
- Excellent written and oral communication skills.
Desirable
- Experience of Digital EDC systems.
- Strong knowledge of EDC processes and procedures.
- Ability to work under pressure and meet deadlines.
- Ability to work in a team, coordinate colleagues, contractors and consultants.
- Strong initiative and the ability to proactively identify required tasks.
- An organized approach to working, task prioritization and time management.
Special Credentials / Certifications Required:
- Must have Engineering Documentation Control experience in a pharmaceutical start up situation
Total working Experience:
- 10+ years EDC
Education Required:
- Bachelor's degree is preferred, Diploma will suffice; in Engineering, Business, Operations, etc.
